Nonmedical - Consent

• Consent form templates
• Assent
     Templates
     Parental permission
     Child assent requirements
• Informed Consent Checklist - IRB Members use this when reviewing consent forms. We hope this information helps investigators understand what the IRB looks for in a consent form.
• Consent terms
      Glossary of lay terms
      Full consent
      Waiver or alteration
      Waiver of documentation
• International research
• Vulnerable classes of participant
• Guidance:
      - Basic Research Consent Requirements
      - General Requirements for Informed Consent
• Non-English speaking participants
      Translating the consent document
      Short form consent process
• Special Stanford University situations

• Nonmedical Consent Form Template
• Parent or Legally Authorized Representative Permission Form Template [doc]
• Stanford University Oral Consent Script Template[html]
• Stanford University Video Use Consent Template [html]

HIPAA (Health Insurance Portability and Accountability Act) might apply if your research involves collecting or using PHI (Protected Health Information). Visit the Stanford HIPAA website for more information. If HIPAA does apply, there might be additional requirements for your research. Questions?  Contact the HRPP Education Specialist (650) 724-7141 or IRBeducation@stanford.edu.

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Assent
Parental permission: When children are included as research subjects, in most circumstances parental permission must be obtained (see Parental Permission and IRB Guidance For Investigators on Consent for Protocols Involving Children and Consenting Minors).

Child assent: When children are included as research subjects, their assent must generally be obtained. See IRB Guidance For Investigators on Consent for Protocols Involving Children and Consenting Minors and Additional Protections for Inclusion of Children in Research - OHRP.

• Assent Form Template
• Parental Permission signature section for 45 CFR 406.7 - use only when directed by IRB.

Consent Terms
The IRB has provided a Glossary of Lay Terms for Use in Preparing Consent Forms. The glossary will open in a separate browser window.

Full consent: Written, signed consent should always be sought unless there are compelling reasons to seek an alteration or waiver of consent or waiver of documentation (e.g., signature) (see below).

Waiver or Alteration: The criteria for a waiver or alteration of consent are explained in the guidance Regulations for Waiver or Alteration of Consent Requirements.



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International research - Waiver or alteration of consent
For international research see Alteration or Waiver of Consent and Waiver of Documentation in Nonmedical Research and International Research.


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Vulnerable classes of participants
For guidance on requirements for vulnerable subjects (e.g., children, prisoners, pregnant women, neonates, fetuses), see Guidances.

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Non-English speaking participants
Stanford University is located in a very culturally diverse region of California.  Investigators are encouraged to recruit and include all segments of our community in research, including individuals whose primary language is not English.

Participants who do not speak English should be presented with a consent document written in a language understandable to them.

Written consent documents should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent.  The Stanford HRPP and OHRP strongly encourage the use of a full consent form translated into the participant’s language whenever possible.
 
When all of the participants in a study (i.e., the target population) are anticipated to be non-English speaking, a full translated consent is strongly encouraged.
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Translating the consent document:
When research is being conducted in a language other than English, it is important that consent forms be translated accurately. Procedures for ensuring accurate translation should be described. For further information, contact Translation Services at Stanford Hospital and Clinics at (650) 724-8735 or Interpreter Services at Lucile Packard Children’s Hospital at (650) 497-8371.

See Short Form Consent Process page for translated short form consent templates.

Special Stanford University situations

• Bing Nursery School Studies: Studies conducted at Bing Nursery School are covered under a consent form signed by parents at the beginning of the school year. A copy of the posted study description must be provided.
• Psych 1 Questionnaire Day and Preselection Studies: Studies conducted through the Psych 1 packets are covered under a consent form attached as a cover letter for the packet.